BILL ANALYSIS                                                                                                                                                                                                    



                                                             


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|SENATE RULES COMMITTEE            |                   SB 595|
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                       THIRD READING
                              

Bill No:  SB 595
Author:   Speier (D)
Amended:  4/28/99
Vote:     21

  
  SENATE BUSINESS AND PROFESSIONS COMMITTEE  :  5-0, 4/19/99
AYES:  Figueroa, Kelley, Murray, O'Connell, Speier
NOT VOTING:  Johannessen, Polanco

  SENATE APPROPRIATIONS COMMITTEE  :  7-5, 5/17/99
AYES:  Johnston, Alpert, Bowen, Burton, Escutia, Karnette,  
  Perata
NOES:  Johnson, Kelley, Leslie, McPherson, Mountjoy
NOT VOTING:  Vasconcellos
 

  SUBJECT  :    Outpatient settings:  health facilities

  SOURCE  :     Author

 
  DIGEST  :    This bill expands the definition of outpatient  
settings that are subject to accreditation, and to  
regulation by the Medical Board of California, and adds  
several requirements for outpatient setting accreditation.

  ANALYSIS  :    Existing law:

1.Provides for the licensure and regulation of  
  clinics, as defined, and health facilities, as  
  defined, by the State Department of Health Services  
  (DHS).

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2.Provides for the licensure and regulation of  
  physicians by the Medical Board of California in the  
  State Department of Consumer Affairs (DCA).

3.Provides for the regulation of outpatient settings  
  by the Division of Licensing of the Medical Board;  
  and

   A.   Defines an "outpatient setting" as:  any  
     facility, clinic, unlicensed clinic, center,  
     office, or other setting that is not part of a  
     licensed general acute care facility, where  
     specified anesthesia is used in compliance with  
     community standards, in doses that when  
     administered have the probability of placing a  
     patient at risk for loss of his or her  
     life-preserving reflexes.

   B.   Excludes from the definition of outpatient  
     settings:  local anesthesia, peripheral nerve  
     blocks, and anxiolytics and analgesics  
     administered in compliance with the community  
     standard of practice in doses that do not meet  
     the level specified in (A).

4.Prohibits any physician from performing surgery in  
  an outpatient setting using the level of anesthesia  
  specified in 3) (A) above, unless the setting is one  
  of enumerated health care settings, including a  
  setting that is accredited by an accreditation  
  agency approved by the Medical Board's Division of  
  Licensing.


This bill:

1.Expands the definition of an "outpatient setting"  
  that is subject to regulation by the Medical Board  
  by deleting the current meaning based on a specified  
  level of anesthesia and, instead, applying it to  
  facilities where any anesthesia, including  
  intravenous, intramuscular, or rectal sedation or  
  analgesia, is administered but excluding local  







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  anesthesia, minor blocks, or minimal oral  
  tranquilization.

2.Prohibits, on or after July 1, 2000, physicians from  
  performing procedures in unaccredited outpatient  
  setting using any anesthesia other than local  
  anesthesia, minor blocks, or minimal oral  
  tranquilization.

3.Requires outpatient settings to post, in a readily  
  visible place, its accreditation certificate, the  
  name and telephone number of the accreditation  
  agency, and instructions on the submission of  
  complaints.

4.Requires accredited outpatient settings, as well as  
  settings that are excluded from accreditation  
  requirements, to have a minimum of two staff  
  persons, including one licensed health care  
  professional present whenever there is a patient on  
  the premises who has not been discharged from  
  supervised care.  Also, requires both types of  
  settings to have written discharge criteria and  
  makes it unprofessional conduct to transfer a  
  patient who does not meet the discharge criteria.

5.Requires the Division to notify the public, upon  
  inquiry, whether an outpatient setting's  
  accreditation has been denied.

6.Requires an accreditation agency to notify the  
  Division of the reasons for denial of an outpatient  
  setting's accreditation, and requires an outpatient  
  setting that has been denied accreditation to wait  
  at least one year after notification of  
  accreditation denial before reapplying for  
  accreditation.

According to the Senate Business and Professions  
Committee analysis:

1.Purpose.  According to the author, SB 595 is  
  intended to clear up the ambiguity regarding the  
  anesthesia threshold for triggering accreditation of  







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  an outpatient setting.  Concerns have been raised  
  since the enactment of the outpatient setting law in  
  1994 by the author's AB 595.  According to the  
  author, this has led to misinterpretation of the law  
  and circumvention of the accreditation requirement  
  by those it was intended to regulate.  The author  
  states the bill provides a clear "bright-line"  
  definition for determining which facilities must be  
  accredited.

2.Background.  According to the author, the Federal  
  Office of the Inspector General reports that more  
  than 51 percent of all surgery which traditionally  
  has been performed in regulated hospitals is now  
  performed in ambulatory centers, clinics, physician  
  offices and other outpatient settings.  By the year  
  2000, it is estimated that 87 percent of all  
  surgeries will be performed in non-hospital  
  settings.  AB 595 (Speier, Chapter 1276, Statutes of  
  1994) was enacted to regulate unlicensed outpatient  
  settings where specified levels of anesthesia are  
  used.  The purpose of that legislation was to  
  provide some additional protection to patients  
  undergoing surgery in those environments. Since  
  enactment, approximately 400 office-based surgery  
  facilities have become accredited outpatient  
  settings.

  FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  Yes    
Local:  Yes

According to the Senate Appropriations Committee:

                Fiscal Impact (in thousands)

  Major Provisions               1999-2000              
  2000-01   2001-02     Fund  

Medical Board    potential increase in regulated  
settingsCFMB*

*Contingent fund of the Medical Board

  SUPPORT  :   (Verified  5/19/99)







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Medical Board of California
California Society of Anesthesiologists
California Society of Plastic Surgeons

  OPPOSITION  :    (Verified  5/19/99)

California Medical Association
California Dermatology Society

  ARGUMENTS IN SUPPORT  :    According to the author,  
there has been ongoing disagreement as to the precise  
meaning of the anesthesia standard in current law that  
triggers accreditation requirements and related  
patient safety measures.  The author believes that the  
subjectivity and ambiguity of the current anesthesia  
standard has made it difficult to properly enforce the  
law, thereby allowing some outpatient centers to avoid  
the accreditation requirements and placing their  
patients in jeopardy.  The author believes that the  
bill will provide a more definite and enforceable  
anesthesia standard that provides a reasonable basis  
for determining when specified safety requirements  
should be required.

  ARGUMENTS IN OPPOSITION  :    The California Medical  
Association (CMA) opposes the change in the anesthesia  
standard that triggers accreditation because of the  
change in focus from the effect on a patient to one  
that specifies particular modalities of anesthesia  
administration.  The CMA wants more information from  
the Medical Board regarding patient harm cases and  
issues directly related to the use of the current  
definition.  Additionally, CMA believes that the new  
standard will subject physician offices that do not  
engage in procedures of significant risk to patients  
to unnecessary accreditation regulation.



In addition, CMA opposes the bill's requirement that  
there be two staff, one of whom is a licensed health  
professional, present whenever a patient is on the  
premises.  CMA believes this staffing level may be  







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unnecessary in certain settings, should not be applied  
equally to accredited and unaccredited settings, and  
that any staffing standards should be included in a  
setting's discharge criteria rather than as an  
independent requirement.
Lastly, CMA opposes the requirement that the Medical Board  
report accreditation denials to the public upon inquiry  
because it believes that an outpatient setting could  
potentially be harmed by such a disclosure which may have  
resulted from a defect that was easily correctable and  
corrected by the setting.  Further, the CMA opposes making  
an outpatient setting wait 12 months after a denial of  
accreditation before it may reapply because the denial may  
have resulted from a defect or defects that are easily  
correctable in a much shorter period of time.

CP:kb  5/19/99   Senate Floor Analyses 

               SUPPORT/OPPOSITION:  SEE ABOVE

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